FOCUS FEATURE: State of the Field 2016

The report is compiled through input from surveys distributed each year to focused ultrasound sites and manufacturers around the globe. To ensure that future reports are accurate and comprehensive, please make sure that your organization completes the survey on time.

The Focused Ultrasound Field is Growing

Every year we survey stakeholders to assess and report on where the field of focused ultrasound has been, where it is now, and where it is going.

The past year has witnessed tremendous growth. There was a remarkable increase of 30% in patients treated in 2015 compared to 2014. These treatments were conducted at 20% more commercial sites than the previous year. Thanks in part to the recent US FDA approval of two systems to treat the prostate, we expect a continued increase in US commercial sites this year.

The establishment of three new companies around the world affirms confidence for success.

This report helps researchers and industry identify possible collaborators, assists patients in locating treatment sites, and illuminates the potential of the technology for reporters, investors, and other stakeholders.

The key statistics and trends identified in the 2016 Report are compiled from data gathered in 2015.

Milestone Surpassed in Patient Treatments

In 2015, the field of focused ultrasound surpassed its 100,000th patient treatment to date. In total, 25,000 patients were treated either commercially or in a clinical trial throughout the year, more than triple the 8,000 patients treated in 2014. Prostate cancer continues to lead as the most treated condition, representing nearly half of all treatments. Uterine fibroids saw a 60% increase in treatments over the previous year, solidifying its spot as the second most common application.

Clinical Experience with Focused Ultrasound Expanded

Two first-in-human treatments were successfully conducted in 2015. In South Korea, a patient was treated for depression, expanding the psychological disorders that focused ultrasound could potentially treat. The blood-brain barrier of a patient in Canada was successfully opened, enabling the possibility of delivering drugs directly to the brain with minimal systemic adverse effects.

New Regulatory Approvals in the United States and Korea

Eight companies have developed focused ultrasound systems that are now approved to treat 19 medical conditions. The US Food and Drug Administration (FDA) approved SonaCare’s Sonablate and EDAP’s Ablatherm for the ablation of prostate tissue in the fourth quarter, opening up the world’s largest commercial market to the leading use of the technology. Insightec has filed with the FDA to obtain approval of their ExAblate Neuro system to treat essential tremor, which would become the first commercially approved neurological indication in the US.

Meanwhile, the Korean Ministry of Food and Drug Safety approved ExAblate Neuro for the treatment of movement, pain, and behavioral disorders including depression and obsessive-compulsive disorder. This marks the first regulatory approval of a focused ultrasound system for psychiatric disorders.

New Commercial Treatment Sites

Eighty new commercial treatment sites were established in 2015, representing a 20% increase over the last year. The number of commercial sites in the US has already doubled since the prostate tissue approvals at the end of 2015, and growth is expected to continue exponentially in the US through 2016. The majority of treatment sites are still in Europe; however, Asia, the second largest region for commercial sites, showed strong growth by adding 34 new sites compared to 30 in Europe.

New Companies Join the Field

Three new focused ultrasound companies joined the field in 2015, raising the number of manufacturers to 32. EpiSonica is a Taiwanese company that has created a supine MRI-guided focused ultrasound system for the treatment of uterine fibroids and other women’s health issues. NaviFUS is another company from Taiwan that is in the early stages of development of a drug delivery system for the brain. And Promedica Bioelectronics, based in Italy, is primarily a diagnostic imaging and oncologic therapy device supplier that has created a bench-top focused ultrasound system for in vitro pre-clinical research.